This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.

A Single-center, Prospective, Phase II Study of Albumin-bound Paclitaxel (Nab-paclitaxel) and Carboplatin With or Without Trastuzumab (Herceptin) as Neoadjuvant Therapy in Locally Advanced Breast Cancer

Willing to coordinate with a punch biopsy before treatment and accept neoadjuvant therapy

Women of child-producing potential must agree to use effective contraceptive methods during the study, and a negative serum or urine pregnancy test must be obtained within 7 days prior to administration of the drugs

Written informed consent

For HER-2 positive patients, the HER-2 status must be determined by ICH +++ or FISH/CISH. For patients treated with trastuzumb, LVEF≥55% by ultrasonic cardiogram or MUGA scan

Exclusion Criteria:

Previous systematic or local therapy including chemotherapy for breast cancer

Not willing to accept a punch biopsy before treatment and neoadjuvant therapy

Psychopath or any other reasons that would preclude compliane with treatment

Known serious allergy to any of the study drugs or excipients

Participation in another study requiring administration of an in investigational drug or biological agent at present or recently (within the last 30 days prior to screening visit)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625429